Intensive Compared With Nonintensive Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known if stronger doses of chemotherapy given over a longer period of time are as well tolerated or as effective as less intensive chemotherapy.

PURPOSE: This randomized phase III trial is studying intensive regimens of chemotherapy to see how well they work compared to nonintensive regimens of chemotherapy in treating older patients with acute myeloid leukemia or myelodysplastic syndrome.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Leukemia Research Fund
• Treatments: Cytarabine; Daunorubicin; Etoposide; Hydroxyurea; Idarubicin; Mitoxantrone; Thioguanine; Tretinoin

Criteria

DISEASE CHARACTERISTICS:

• Acute myeloid leukemia (de novo or secondary) OR

• Myelodysplastic syndrome

• More than 10% myeloblasts in the bone marrow

• Refractory anemia with excess blasts

• Refractory anemia with excess blasts in transformation

• Chronic myelomonocytic leukemia

• No acute promyelocytic leukemia (FAB type M3)

• No blastic phase chronic myeloid leukemia

PATIENT CHARACTERISTICS:

Age:

• 60 and over (younger patients allowed if intensive chemotherapy not indicated)

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• No liver function test ≥ 2 times normal (for non-intensive therapy arm)

Renal:

• Not specified

Cardiovascular:

• No myocardial infarction within past 6 months in patients receiving daunorubicin or PSC 833

Other:

• No other concurrent active malignancy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior cytotoxic chemotherapy for leukemia

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• Not specified